NZ227875A

NZ227875A - Pediatric medication inhaler: flexing bubble indicates breathing

Info

Publication number: NZ227875A
Application number: NZ227875A
Authority: NZ
Inventors: Christopher Nowacki; Alfred Glen Brisson; Exequiel Dela Cruz
Original assignee: Trudell Medical
Priority date: 1988-05-19
Filing date: 1989-02-07
Publication date: 1990-12-21
Also published as: CA1301001C; US4832015A; JPH0548708B2; JPH01320067A; AU618789B2; AU3080489A; PH24829A; KR910005214B1; BR8901027A; KR890016981A; FI891690A; PT90600A; FI891690A0; EP0344879A1

Description

<div class="application article clearfix" id="description"> 227875 c 0 Priority Date(s): ... Complete Specification Filed: i.zm. Class: Publication Date: ?. .LDIECJ9SQi. .. P.O. Journal, No: . ,....IS3>3 NEW ZEALAND PATENTS ACT, 1953 No.: Date: COMPLETE SPECIFICATION IMPROVED PEDIATRIC ASTHMATIC INHALER I •J/We, TRUDELL MEDICAL,I a Partnership! of 926 Leathorne Street, London, /NSZ SMS 0ntario7&6A 4Wfr, Canada, ~ i Hi p ^ y&cM LfcAiUvJ^ (Alloer^ "17 Uf /f£v hereby declare the invention for which £'! we pray that a patent may be granted to rrie/us, and the method by which it is to be performed, to be particularly described in and by the following statement: - - 1 - (followed by page la) Background 0£ The Invention / w « "'.an °C?i /v " * // ■?„•' -n\ \^'.'V7.V / A person suffering from Asthma may have rather considerable trouble"--iff g breathing when suffering from an asthmatic attack, due to the sweirifi^^n the bronchii and due to secretion of mucous. There are various anti-asthmatic^? pills that are effective, which generally are somewhat slow acting. There are also medications available for intravenous treatment which work quite rapidly, but which require administration by skilled medical personnel. For most ( J patients the promptest, immediately available relief is by way of an inhalant. Epinephrine or other suitable asthmatic medication is packaged with a suitable diluent in a small pressurized canister or cartridge which interfits with a mouthpiece. The patient places the mouthpiece in his rrouth, and depresses the cartridge, thereby releasing a measured amount of medication which is inhaled through the mouthpiece. Some patients do not inhale properly, and the mouthpiece may not be completely effective in cooperation with the cartridge to convert the medication into a mist which is deposited in the proper bronchial area to relieve the asthmatic attack. Often there are small droplets, rather than a mist, and this may be compounded by improper inhalation which results in much - la- 227875 r IMPBOVED PEDIATRIC ACTHHATIC IMIflLER OCtrEIHUIID of the medication simply going into the throat and stomach where it is ineffec- r—v. tive against the asthmatic attack. ( In the prior U.S. Patent 4,470,412 in the names of Christopher Nowacki and Alfred. G. Brisson, there is disclosed a remarkably efficient and low cost inhalation valve in the nature of an extended mouthpiece for a broncho dialator which aids the asthmatic sufferer in properly inhaling, and in breaking up droplets into a mist form. This inhalation valve has achieved extensive commercial success. The inhalation valve as discussed above is for use by a patient who can take the mouthpiece thereof into his mouth and inhale and exhale through the mouthpiece. Infants, including babies and small children, cannot be relied upon properly to hold the mouthpiece in the mouth, and indeed, the infant's mouth may be too small for the mouthpiece. Furthermore, it cannot be ascertained with certainty under some conditions whether a baby or small child is properly inhaling and exhaling. In US Patent Specification No 4809692, there is disclosed ( „• v"*!" pediatric asthmatic inhaler which includes a mask-like adaptor fitting over the infant's mouth and nose and sealing to the face, whereby breathing by the infant effects proper inhalation, and exhalation through the valve. A whistlelike device is provided in the adaptor which generates sound upon either or o both inhalation and exhalation, whereby a party applying the inhalation valve and medication to an infant may be sure that the medication is being breathed in. This prior pediatric asthmatic medication inhaler works satisfactorily under most conditions. However, for an infant, particularly a baby, in which the volume of inhalation or exhalation may be rather small, and wherein the -2- r 227875 3MPB0VED PEDIATRIC ASTHMATIC INHALER CONTINOEP- inhalation or exhalation might also be rather weak, the sound generated is not very loud. Under some circumstances in a noisy environment it may be difficult to hear the sound, and with very low-level respiration the whistle may fail to generate any audible sound. The tapered foam molding of the inhaler requires a rather expensive mold, and the whistle must be inserted as a separate manufacturing step, or requires sophisticated molding techniques if the whistle is to be molded in place. Objects And Suitmary Of The Present Invention It is an object of the present invention to provide an improved pediatric asthmatic inhaler which is less expensive to produce, which provides a nore positive indication of inhalation and expiration, and which is longer lasting. More particularly, it is an object of the present invention to provide such an inhaler made of flexible plastic material, and having a "bubble" of relatively thin, integral construction which is normally convex outwardly upon exhalation or rest, but which deflects inwardly upon inhalation. In accordance with the present invention, there is provided an inhalation device similar to and incorporating the advantages of the pediatric asthmatic medication inhaler disclosed in US Patent 4809692 incorporating a mask-like adaptor which fits over the nose and mouth of an infant. The adaptor is molded of flexible, resilient plastic material having sections of uniform thickness, and further including an integral bubble. The bubble is normally convex outwardly, and retains its shape upon exhalation or rest. However, upon inhalation, even of a small degree, the bubble will flex inwardly, where by the adult administering the device may readily obsei -3- 22 7 8 7 5 ■ IMPROVEB- PEDIATRIC ftgDOMftTIC INHALER CONTINUE— visually. The plastic material is of uniform consistency free of bubbles. I.e., it is not a foam, and thereby it is simpler and quicker in molding. The Drawings The invention will best be understood with reference to the following text when taken in connection with the accompanying drawings wherein: Fig. 1 is a perspective view of an improved pediatric asthmatic inhaler constructed in accordance with the present invention; Fig. 2 is a side view thereof; Fig. 3 is a right end view thereof; Fig. 4 is a left end view thereof; Fig. 5 is a longitudinal sectional view taken substantially along the line 5-5 in Fig. 3; Fig. 6 is a side view of the inhaler as applied to an infant's face and upon inhalation; and Fig. 7 is a view similar to Fig. 6, but taken upon exhalation. Detailed Disclosure of the Illustrated Embodiment As is well known, and as is summarized in prior U.S. Patent 4, 470, 412, a small pressurized canister or cartridge, sometimes referred to as a nebulizer, is charged with epinephrine or other suitable anti-asthmatic medication and a suitable diluent, and under pressure. The cartridge fits into a receiving end of a right angle mouthpiece, the opposite end of which is placed in the asthmatic sufferer's mouth. The cartridge is pressed down, being squeezed between the index finger and thumb underlying the mouthpiece. This causes a valve stem in the cartridge to press against the reaction base in the mouthpiece to discharge a measured quantity of medication into the mouthpiece. The discharge is 227875 iMPnovED prcnTftTnTr Acrnmyric DUIALER OONTINUIIB- supposed to be in the form of a mist, but in fact often contains small droplets. The patient inhales and the mist passes into the mouth and hopefully into the bronchial tubes to provide asthmatic relief. The patient is then supposed to hold his breath for a short time, and subsequently to inhale slowly through nearly closed lips. However, as noted heretofore, some of the medication may simply be in the form of droplets rather than mist, and the droplets generally are simply swallowed and do not reach the bronchial tubes to effect their intended purpose. As is disclosed in detail in the aforesaid prior Patent 4,470,412, the drops can be broken up into a mist, and the patient can be more or less forced to inhale properly through the use of the inhalation valve forming the subject matter of said patent. Only a portion of the valve is shown herein for an understanding in combination with a pediatric adaptor or face mark. Such an inhalation valve 14, is shown fragmentarily in Figs. 6 and 7, and comprises a cylinder 16 preferably molded of a suitable plastic material. The end of the inhalation valve 14 to which the right angle mouthpiece carrying the medication canister is not shown, but this is well-known, and for example is shown in aforesaid U.S. Patent 4,470,412. A resinous plastic or elastomeric diaphragm 44 is disposed adjacent the end of the cylinder 16 and is provided with a horizontal slit 46. A spider (not shown) lies upstream of the diaphragm 44 and backs up the diaphragm so that the diaphragm cannot flex upstream (to the right in Fig. 6) but only downstream upon inhalation. Further details of the diaphragm structure may be seen in aforesaid U.S. Patent 4,470,412, or in US Patent 4809692. »*— The pediatric asthmatic inhaler of the present invention is complet -5- ( r IMPROVED PEDIATRIC A3PMATIG IMIIALER OONTHffJE& 22 7 8 7 5 an adaptor or fitting 36 in the nature of a face mask. The adaptor 36 is molded of a soft plastic material of uniform consistency and density, such as polyethylene. The adaptor 36 is axially open and continuous, and at its entering end has a short section 48 of initially very shallow taper, and which is deformed substantially into cylindrical shape upon encircling and gripping the entering end of the inhalation valve 14. A frustoconical section 50 of slightly greater taper than the section 48 flares outwardly from the section 48. Finally, a face engaging portion 52 flares outwardly from the section 50 at a rouch shallower angle. The face engaging portion 52 is adapted to engage the face of an infant 54 in sealing engagement so as to prevent ingress or egress of air between the fitting 36 and the face. The difference in taper between the sections 48 and 50 is so little that there is scarcely any parting line visible, but one is shown at 54 in the drawings to illustrate the difference in taper. There is a definite parting line 56 between the center section 50 and the section or flange 52, although this is not so much a definite line as it is a sharply curved or rolled area. An upstanding bubble or blister 58 extends radially outwardly from the adaptor or fitting 36, being integral therewith, and has a rounded end or nose 60 terminating substantially at the parting line 54. Except for the nose the blister is slightly less than a semicylinder and terminates at a short cylindrical section 62 of thickened material affording a shape having a certain degree of stability to the rear end of the bubble or blister 58. From the section 62 an extended portion of the flange 52 extends generally radially outwardly at 64 and lies generally over the ridge of the nose of the infant 54, conforming to the shape of the adjacent portion of the face. -6- IMPROVED PEDIATRIC ASTHMATIC INHALER OONTIfflJEP- n 7R7 Various sections or portions of the adaptor or fitting 36 are of different thicknesses for controlled flexibility. The particular dimensions of a specific example include an inside diameter of the inhalation valve cylinder 16 receiving portion 48 of approximately 35 mm. This and other cross sections being substantially circular. The thickness of this portion is 2.8 mm. The axial length of this section is on the order of 10-12 mm. depending on just where the somewhat indefinite line of demarcation 54 is located. The intermediate section 50 has an axial length of about 22 or 23 mm. The thickness is approximately 1.8 mm. The internal diameter at the parting line or rule 56 is approximately 40 mm. It should be noted that the first section 48 has an entering internal taper 66 having an axial length of about 10 mm. The thickness of the first portion 48 at the entering end is approximately 2.5 mm. The final section or flange 52 is approximately 1 mm. in thickness, the axial length is approximately 20 mm., and the exit diameter is approximately 66 mm. The thickness of the bubble or blister 58 and of the flared nosepiece 64 is approximately .3 mm. The thickness of the intermediate strengthening i portion 62 is approximately 1.6 mm. at the forward shoulder 62 thereof, and tapers to about .8 mm. at the junction with the flared nosepiece 64, such junction hereinafter being identified by the numeral 70. The bubble 58, including the rounded nose 60 thereof is approximately 21 mm. in length axially of the adaptor or fitting 36 and forwardly of the shoulder 68. The bubble is approximately 20 mm. in width. As is shown in Figs. 6 and 7 the rear portion or flange 52 adapts by flexing to accommodate fully to the face of the infant 54, even though the adaptor or fitting 36 might be used on infants of rather substantially -7- o . IMPPDVED PEDIATRIC A3TOHATIC IMIIALER CONTINUED 227875 different sizes. The flange forms an airtight seal with the face. Thus, when the patient is exhaling, or is resting between breaths, the bubble extends outwardly as shown in Fig. 7. However, when the patient inhales as shown in Fig. 6 the decreased pressure within the adaptor causes the bubble to deflect inwardly as at 72 under the pressure of exterior anbient air as indicated by the arrow 74. It is thus easy for the person administering the medication to observe inhalation, even in a noisy environment. The shiny exterior appearance of the plastic material allows the deflection to be seen even in rather dim light. Reference has been made to asthmatic medication, but it will be apparent that other medications could be inhaled with the present invention. The specific example is for illustrative purposes only. Various changes will no doubt occur to those skilled in the art, and will be understood as forming a part of the invention insofar as they fall within the spirit and scope of the appended claims. </div>